In-use physicochemical and microbiological stability of biological parenteral products

被引：21

作者：

Ricci, Margaret Speed ^{[1
]}

Frazier, Michelle ^{[2
]}

Moore, Jamie ^{[3
]}

Cromwell, Mary ^{[4
]}

Galush, William J. ^{[4
]}

Patel, Ankit R. ^{[5
]}

Adler, Michael

Altenburger, Ulrike

Grauschopf, Ulla

Goldbach, Pierre

Fast, Jonas L. ^{[6
]}

Kraemer, Irene ^{[7
,8
]}

Mahler, Hanns-Christian ^{[6
]}

机构：

[1] Genentech Inc, Drug Prod Dev, Proc Dev, San Francisco, CA 94080 USA

[2] Amgen Inc, Regulatory Affairs, Thousand Oaks, CA USA

[3] Genentech Inc, Early Stage Pharmaceut Dev, San Francisco, CA 94080 USA

[4] Genentech Inc, Late Stage Pharmaceut Dev, San Francisco, CA 94080 USA

[5] Genentech Inc, Early Stage Pharmaceut Dev, Pharmaceut Dev, Pharma Tech Dev Biol US, San Francisco, CA 94080 USA

[6] F Hoffmann LaRoche Ltd, Pharmaceut Dev & Supplies, Pharma Tech Dev Biol EU, Basel, Switzerland

[7] Johannes Gutenberg Univ Hosp, Dept Pharm, Med Ctr, Mainz, Germany

[8] Johannes Gutenberg Univ Hosp, Sch Pharm, Clin Pharm, Mainz, Germany

来源：

AMERICAN JOURNAL OF HEALTH-SYSTEM PHARMACY | 2015年 / 72卷 / 05期

关键词：

MONOCLONAL-ANTIBODY; ANTICANCER DRUGS; INFUSION BOTTLES; INSULIN; CONTAMINATION; DELIVERY; BAGS; COMPATIBILITY; ALEMTUZUMAB; ADSORPTION;

D O I：

10.2146/ajhp140098

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

引用

页码：396 / 407

页数：12

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